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Clinical Trial Record

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A Trial of Cabozantinib (XL184) and Gemcitabine in Advanced Pancreatic Cancer

2012-07

2015-01

2017-03-01

12

Study Overview

A Trial of Cabozantinib (XL184) and Gemcitabine in Advanced Pancreatic Cancer

Gemcitabine is considered one of the standard drugs for advanced pancreatic cancer and is approved by the FDA to treat it. Cabozantinib is a new drug that has demonstrated effectiveness against pancreatic cancer in laboratory experiments, especially when given with gemcitabine. Initial studies with cabozantinib in pancreatic cancer have shown some activity against the disease. The purpose of this study is to determine the safest and highest dose of cabozantinib that can be given together with standard doses of gemcitabine in patients with pancreatic cancer. This study will determine the safety and tolerability of this two drug combination.

Preclinical work at the University of Michigan has demonstrated that inhibition of c-Met with cabozantinib prevented the development of metastatic disease in an intra-cardiac injection model in NOD/SCID mice. Additionally, the combination of cabozantinib and gemcitabine demonstrated improved tumor control compared to either agent alone in a relevant orthotopic implantation mouse model. Combining gemcitabine with the c-Met inhibitor cabozantinib in advanced pancreatic cancer is a novel strategy that takes advantage of an established cytotoxic agent with one that targets a pathway known to be important for the growth, dissemination, and resistance of this disease.

  • Pancreatic Cancer
  • DRUG: CABOZANTINIB
  • DRUG: gemcitabine
  • UMCC 2011.105
  • HUM 62927 (OTHER Identifier) (OTHER: University of Michigan IRBMED)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2012-07-24  

2017-05-18  

2018-09-18  

2012-08-08  

2018-09-18  

2018-09-19  

2012-08-13  

2018-09-19  

2018-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: cabozantinib with gemcitabine

The Study Treatment Period will consist of continued treatment during which time patients will receive cabozantinib and gemcitabine until either disease progression or the occurrence of unacceptable drug-related toxicity

DRUG: CABOZANTINIB

  • Daily oral cabozantinib administered days -7 until disease progression, intolerable adverse event(s) or patient choice.

DRUG: gemcitabine

  • Gemcitabine administered intravenously on days 1, 8, and 15 every 28 days.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Maximum Tolerated DoseThe MTD is defined at the highest dose level at which ≤25% of patients experience a dose-limiting toxicity (DLT).5 weeks
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Median Progression-free Survival (PFS)Progression-free survival (PFS, a secondary endpoint) will be calculated from day-7 of cycle 1 of study treatment, until documented disease progression or death. Patients removed from treatment for progression or other reasons will be followed for 30 days after their last dose.day-7 of cycle 1 until 30 days post treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. pathologically confirmed pancreatic carcinoma. 2. locally advanced unresectable disease, metastatic disease, or recurrent disease following surgical therapy. 3. ≥ 18 years old. 4. Life expectancy of greater than 12 weeks. 5. ECOG performance status ≤1 (Karnofsky ≥70%) (See Appendix A). 6. adequate organ and marrow function as follows: 7. capable of understanding and complying with the protocol requirements and has signed the informed consent document. 8. use medically accepted barrier methods of contraception 9. women of childbearing potential must have a negative pregnancy test at screening.
    Exclusion Criteria:
    1. neuroendocrine tumors of the pancreas. 2. more than 1 prior systemic treatment regimen for pancreatic cancer. may have received prior neoadjuvant or adjuvant therapy, including gemcitabine, provided 6 months have elapsed from completion of that treatment and the start of study therapy. 3. Previous gemcitabine therapy for advanced pancreatic cancer. Patients who have had chemotherapy within 4 weeks, nitrosoureas/mitomycin C within 6 weeks, or monoclonal antibody within 6 weeks prior to planned initiation of study treatment. 4. prior treatment with a small molecule kinase inhibitor or a hormonal therapy within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment. 5. have received an investigational agent within 28 days of the first dose of study treatment or 5 half-lives of the compound or active metabolite, whichever is longer. 6. have received radiation therapy within 14 days of study treatment. 7. have not recovered from toxicity due to all prior therapies (i.e., return to pretherapy baseline or to CTCAE Grade 0 or 1) except alopecia and non-clinically significant AEs. 8. known brain metastases.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Mark Zalupski, MD, University of Michigan Rogel Cancer Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • Zhen DB, Griffith KA, Ruch JM, Camphausen K, Savage JE, Kim EJ, Sahai V, Simeone DM, Zalupski MM. A phase I trial of cabozantinib and gemcitabine in advanced pancreatic cancer. Invest New Drugs. 2016 Dec;34(6):733-739. doi: 10.1007/s10637-016-0376-1. Epub 2016 Jul 21.
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